FDA Approved Rapid Antibody Test for Hepatitis C

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One confirmatory diagnostic test for hepatitis C is the Rapid Antibody Test (RAT). Since the symptoms of hepatitis A, B, C, D and E overlap, it is possible that a misdiagnosis will occur until a blood test is run for the type of viral infecting the system. The HCV Rapid Antibody Test helps detect the presence of hepatitis C antibody in the venous blood of the person.

A sample of blood is taken from the infected person and is put into a vial for chemical testing to check the presence of proteins that fight the hepatitis C viral. The good thing is that the blood is not drawn from the inner arm. The finger is pricked using a microfilm needle.

The test not only helps determine of the person is currently harboring the hepatitis C virus (HCV) or was infected with it at some time in the past. The HCV Rapid Antibody Test takes approximately 20 to 40 minutes to analyze for hepatitis C and is said to be 99 percent accurate. (Source: MedPage Today; Report Title: FDA Okays Finger Stick for Hep C Test; Author: Cole Petrochko; Date: February 23rd, 2011; URL: http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/25027 )

Though the U.S. Food and Drug Administration (FDA) had given its initial approval for the test kit in June, 2010, it was undergoing further testing and trials at the FDA and it was only given the green signal for its marketing now in March, 2011 (Letter of Approval from the U.S Department of Health and Human Services: http://www.accessdata.fda.gov/cdrh_docs/pdf8/p080027s001a.pdf). It will market under the name of OraQuick HCV Rapid Antibody Test Kit. This product comes from OraSure Technologies Inc., a corporation that develops easy-to-use tools for critical health care situations, such as HIV testing, substance abuse testing, etc.

However, the OraQuick HCV Rapid Antbody Test is not to be used as a stand-alone confirmatory test for diagnosis of the HCV pointing at hepatitis C. It is to be used in conjunction with blood test used to aid the diagnosis of those exhibiting the symptoms of hepatitis C. (Source: U.S Department of Human And Health Services; FDA- U.S Food and Drug Administration; Report Title: OraQuick HCV Rapid Antibody Test - P080027/S001; Last Updated: March 9th, 2011; URL: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm246401.htm)

Cautions:

• Even if the OraQuick’s HCV Rapid Antibody Test gives a positive result, more tests will need to be run to assess if the person in question is infected with HCV
• It is not to be used on asymptomatic patients
• It is not to be run on blood donors
• It is to be used only after receiving a prescription

INFORMATION IN THIS ARTICLE IS NOT MEDICAL ADVICE. ALL INFORMATION GIVEN IS TO BE CHECKED WITH YOUR DOCTOR BEFORE IMPLEMENTING OR TAKING THEM AS STANDARD OR VERIFIED.

Reviewed May 18, 2011
Edited by Alison Stanton

Mamta Singh is a published author of the books Migraines for the Informed Woman (Publisher: Rupa & Co. URL: http://www.amazon.com/Migraines-Informed-Woman-Tips-Sufferer/dp/8129115174/ref=sr_1_2?ie=UTF8&s=books&qid=1298990756&sr=1-2), the upcoming Rev Up Your Life! (Publisher: Hay House India) and Mentor Your Mind (Publisher: Sterling Publishers). She is also a seasoned business, creative and academic writer. She is a certified fitness instructor, personal trainer & sports nutritionist through IFA, Florida USA. Mamta is an NCFE-certified Holistic Health Therapist SAC Dip U.K. She is the lead writer and holds Expert Author status in many well-received health, fitness and nutrition sites. She runs her own popular blogs on migraines in women and holistic health. Mamta holds a double Master's Degree in Commerce and Business. She is a registered practitioner with the UN recognised Art of Living Foundation. Please visit www.mamtasingh.com

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